6-Hour Virtual Seminar on QbD and Technology Transfer Program – A Practical Approach to Successful Implementation

This training will explain the main principles behind a QbD approach and provide guidelines in how to implement the concepts into a pharmaceutical development organization. Quality needs to be built in to the product at design stage. So, we will discuss in detail about this quality by design concept and further technology transfer practices. We will focus on practical approach for developing the product as well as analytical methods and their successful technology transfer in the plant.

This will help you all to be ready and free from any product related problems in future. Or in case of any problems in future, your development and technology transfer team can have ready pragmatic solution on it. We will focus on how ICH Q8 can be used in line with ICH Q9 and ICH Q10. So that, the pharmaceutical quality system will enable the quality product at design stage only and ensure continuous improvements.

Seminar Agenda:

  • Regulatory background and benefits of QbD
  • Quality Risk Management (QRM) (process and tools e.g. FMEA, risk ranking)
  • Designing the Control Strategies
  • PQS & GMP and their link to Control Strategies
  • Design of Experiments
  • Developing a Design Space
  • Process Analytical Technology (PAT)
  • The importance of technology transfer
  • The use of a technical review and Product Strategy Review systems
  • Tools and Templates used for technology transfer
  • Analytical Testing, Validation, Transfer

Who Should Attend:

  • Quality Assurance Departments
  • Quality Control Departments
  • Research and Development Departments
  • Regulatory Affairs Departments
  • Manufacturing Departments
  • Engineering Departments
  • Operations Departments
  • Production Departments
  • Documentation Departments


HitendraKumar Shah

HitendraKumar Shah is a renowned Quality oriented professional with over 20 years of experience in Quality Assurance and Quality Control. During this period, he has been actively involved in process control, Finished product release, Investigations, product recalls and other quality notifications. He has helped numerous companies in ensuring CAPA implementation & effectiveness, Quality system review and reporting, Supplier audit, GMP training, risk assessment and validation activities. His Key Competencies are but not limited to Quality Compliance, Vendor Audit, data integrity, Risk assessment, Qualification & validation, Review and finalization of technical agreements. He is a popular figure on social media for his effective and easily understandable training bites.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance